Nova Biomedical StatStrip Glucose Meter Recalled for Data Error
Nova Biomedical is recalling StatStrip Glucose meters due to a software defect that may assign patient test results to the wrong medical record.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where incorrect data assignment could lead to inappropriate clinical intervention, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Nova Biomedical Corporation is recalling 1,858 units of the StatStrip Glucose and B-Ketone meter, Model No. 63683. The recall covers software versions 0.00.13.10 through 1.5.14.25. The product was distributed nationwide in the US and in 22 foreign countries.
The recall is due to a software synchronization issue that causes the device to intermittently retain previously scanned barcodes, including patient identification and quality control codes. This defect can cause a current patient's glucose result to be incorrectly assigned to a previous patient's medical record, while the current patient's record remains without the result. This may lead to inappropriate clinical interventions, particularly for critically ill patients, neonates, and infants. The defect does not affect the analytical accuracy of the glucose measurements themselves.
Healthcare facilities and users should stop using the affected devices and contact Nova Biomedical Corporation for instructions on remediation or replacement.
The recalled product
- Product
- StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Category
- Medical Device — Glucose Meter
- Affected units
- 1,858
Distribution
Distributed nationwide across the United States.
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